Michelle Orlere

Clinical Research Associate with 8+ years of progressive experience across CRO environments, advancing from CTA to Senior CRA level, supporting Phase I–III global clinical trials across oncology, CNS, cardiovascular, and infectious disease indications. Expert in risk-based monitoring (RBM), SDV/SDR, site lifecycle management (SIV–COV), and eTMF oversight, with a strong track record of improving site compliance, accelerating enrollment, and maintaining audit-ready documentation. Adept at working within ICH-GCP, FDA, and global regulatory frameworks, with hands-on experience across Medidata Rave, Oracle Inform, and Veeva Vault.

Senior Clinical Research Associate at Everest Clinical Research (2024-07 – Present)

• Lead full-cycle monitoring across 8–12 active sites for Phase II–III oncology and CNS trials, managing all visit types (SIV, IMV, COV) while ensuring strict adherence to ICH-GCP and FDA regulations
• Execute risk-based monitoring strategies, prioritizing high-risk data points and critical endpoints, reducing unnecessary SDV effort by 20% while maintaining data quality
• Perform targeted SDV/SDR across EDC systems (Medidata Rave), ensuring >98% data accuracy and minimizing query generation cycles
• Proactively identify protocol deviations, enrollment risks, and site compliance gaps, implementing corrective actions that reduced repeat deviations by 25%
• Partner with Clinical Trial Managers (CTMs) and Data Management to drive timely database lock readiness, ensuring milestone adherence across study timelines
• Oversee eTMF completeness and quality, maintaining inspection-ready documentation with zero critical audit findings
• Evaluate site performance using KPIs (enrollment rate, query turnaround, deviation frequency), driving underperforming sites to meet recruitment targets
• Provide mentorship and oversight to junior CRAs, improving monitoring consistency and report quality across the study team

Clinical Research Associate II at Charles River Laboratories (2022-03 – 2024-06)

• Managed 5–8 clinical sites simultaneously across Phase I–III trials, ensuring protocol compliance and regulatory adherence
• Conducted routine IMVs and remote monitoring visits, reviewing source documents, verifying informed consent, and ensuring accurate EDC data capture
• Led site initiation activities, including investigator training, protocol walkthroughs, and regulatory document verification, reducing startup delays by 15%
• Drove patient enrollment performance, collaborating with site staff to optimize recruitment strategies and improve enrollment rates by 18%
• Reviewed and reconciled SAE/SUSAR documentation, ensuring timely reporting and alignment with safety reporting timelines
• Identified data inconsistencies and query trends, working closely with data management teams to reduce query resolution time by 25%
• Supported internal audits and regulatory inspections, ensuring documentation readiness and adherence to compliance standards
• Strengthened site relationships through consistent communication, improving site responsiveness and data turnaround times

Clinical Research Associate I / In-House CRA at Allucent (2020-06 – 2022-02)

• Supported global clinical trials through remote monitoring and site management support, ensuring consistent compliance across multiple regions
• Assisted in SIV preparation and regulatory submissions, ensuring sites were activation-ready with complete documentation
• Conducted data review, query generation, and resolution tracking within EDC systems, improving data accuracy and consistency
• Maintained eTMF documentation, ensuring completeness and alignment with regulatory requirements
• Tracked protocol deviations and CAPAs, ensuring timely resolution and proper documentation
• Acted as a key liaison between CRAs, data management, and site coordinators to ensure smooth trial execution
• Contributed to audit readiness efforts, ensuring documentation accuracy and completeness

Clinical Trial Assistant (CTA) / Junior CRA at Syneos Health (2017-01 – 2020-05)

• Provided operational and documentation support across Phase I–IV clinical trials, assisting CRAs in monitoring activities
• Managed TMF/eTMF documentation, ensuring essential documents were complete, current, and inspection-ready
• Assisted in monitoring visit preparation and follow-up reporting, ensuring timely submission of trip reports
• Coordinated site communication and investigator queries, improving response turnaround time
• Supported patient enrollment tracking and study progress reporting, contributing to study milestone tracking
• Ensured adherence to ICH-GCP guidelines and sponsor SOPs, building a strong compliance foundation
• Gained hands-on exposure to EDC systems, SDV processes, and clinical trial workflows

Master's in Healthcare Administration – University of North Texas Health Science Centre

Bachelor of Science in Applied & Environmental Biology – Rivers State University